FDA Approves Ocrevus Zunovo™ as the First and Only Twice-a-Year 10-Minute Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis

Rhea-AI Summary

Genentech, a Roche Group member, announced FDA approval of Ocrevus Zunovo™ for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This is the first twice-yearly, 10-minute subcutaneous injection approved for both MS forms, expanding treatment options.

Key points:

• Builds on a decade of Ocrevus® IV safety and efficacy data
• Offers flexibility for healthcare providers and patients
• After the first dose, treatment time could be as little as 55 minutes
• Phase III OCARINA II trial showed consistent efficacy with IV formulation
• 92% of trial participants reported satisfaction with subcutaneous administration

Positive

• First and only twice-a-year, 10-minute subcutaneous injection approved for both RMS and PPMS
• Potential to expand treatment options to centers without IV infrastructure
• Consistent efficacy with IV formulation, showing 97% suppression of relapse activity and MRI lesions
• High patient satisfaction (92%) with subcutaneous administration
• Shorter treatment time (as little as 55 minutes) after the first dose

Negative

• 49% of trial participants experienced injection reactions after the first injection
• Patients require premedication and monitoring post-injection

– Ocrevus Zunovo™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, like at a doctor's office –

– This approval is backed by a decade of proven safety and efficacy data of Ocrevus^® IV, with over 350,000 people treated globally –

– Ocrevus Zunovo™ offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the United States Food and Drug Administration (U.S. FDA) has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.

“Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Today’s approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs.”

“People are living longer with chronic illnesses and with fewer disabilities because of the extensive progress that has been made in the development of medicines that can slow their progression,” said Natalie Blake, Executive Director of the MS Foundation. “But still, not everyone has access to these medicines. It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential. We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time.”

After the first dose, the time for treatment with Ocrevus Zunovo could be as little as 55 minutes. Patients will be required to take premedications at least 30 minutes prior to each dose. Following the first dose, patients will be monitored by their HCP for at least 60 minutes. Patients will be monitored for at least 15 minutes post-injection for subsequent doses.

The FDA approval is based on pivotal data from the Phase III OCARINA II trial, which showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously, and a safety and efficacy profile consistent to the IV formulation in people with RMS and PPMS. Out of the exploratory outcomes measured, Ocrevus Zunovo was consistent with IV, demonstrating suppression of relapse activity (97%) and MRI lesions (97%) through 48 weeks. Additionally, one of several patient-reported outcomes measured during the study showed more than 92% of trial participants reported being satisfied or very satisfied with the SC administration of Ocrevus Zunovo.

In the Phase III OCARINA II trial, the safety profile of Ocrevus Zunovo was consistent with the well-established safety profile of Ocrevus^® IV, with the exception of injection reactions. The most common adverse events with Ocrevus Zunovo were injection reactions. Injection reactions were more frequently reported with the first injection, with 49% of trial participants experiencing an injection reaction after the first injection. All injection reactions were either mild or moderate, and none led to treatment withdrawal.

Genentech is dedicated to advancing innovative clinical research programs to broaden the scientific understanding of multiple sclerosis, further reducing disability progression in RMS and PPMS and improving the treatment experiences for those living with the disease. Genentech has more than 30 ongoing multiple sclerosis clinical trials designed to help us better understand the disease and its progression.

Developing new formulations of our medicines is part of our commitment to improve the patient experience and support people living with different illnesses at every step of their treatment journey. With Ocrevus Zunovo and Roche and Genentech’s 14 subcutaneous therapies – available across various diseases – we offer additional administration options to meet the diverse preferences of patients.

About Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq)

Ocrevus Zunovo combines Ocrevus with Halozyme Therapeutics’ Enhanze^® drug delivery technology.

Ocrevus is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with multiple sclerosis. Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.

The Enhanze^® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing Ocrevus to enter, and enabling it to be rapidly dispersed and absorbed into the bloodstream.

Ocrevus and Ocrevus Zunovo are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, or relapsing secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and PPMS.

About the OCARINA II study

OCARINA II (NCT05232825) was a Phase III, global, multicenter, randomized study that evaluated the pharmacokinetics, safety and clinical and radiological efficacy of the subcutaneous (SC) formulation of Ocrevus compared with Ocrevus intravenous (IV) infusion in 236 patients with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).

The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on Ocrevus levels in the blood, and consistent control of clinical (relapses) and radiological (MRI lesions) disease activity. The safety profile of Ocrevus SC was also consistent with the well-established safety profile of Ocrevus IV with the exception of injection site reactions.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects more than 2.9 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of acquired non-traumatic disability in younger adults.

People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent progression as early as possible.

Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus, there had been no FDA-approved treatments for PPMS and Ocrevus and Ocrevus Zunovo are the only approved treatments for PPMS.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Indications and Important Safety Information

What are OCREVUS and OCREVUS ZUNOVO?

OCREVUS and OCREVUS ZUNOVO are prescription medicines used to treat:

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

Primary progressive MS, in adults.

It is not known if OCREVUS and OCREVUS ZUNOVO are safe and effective in children.

Who should not receive OCREVUS or OCREVUS ZUNOVO?

Do not receive OCREVUS or OCREVUS ZUNOVO if you:

• have an active hepatitis B virus (HBV) infection.
• have had a life-threatening administration reaction to ocrelizumab.
• have had a life-threatening allergic reaction to ocrelizumab, hyaluronidase, or any of the ingredients of OCREVUS ZUNOVO. Tell your healthcare provider if you have had an allergic reaction to OCREVUS or OCREVUS ZUNOVO or any of their ingredients in the past.

What is the most important information I should know about OCREVUS and OCREVUS ZUNOVO?

OCREVUS and OCREVUS ZUNOVO can cause serious side effects, including:

Infusion reactions (OCREVUS): Infusion reactions are a common side effect of OCREVUS, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction.

Injection reactions (OCREVUS ZUNOVO): Injection reactions are a common side effect of OCREVUS ZUNOVO, which can be serious and may require you to be hospitalized. You will be monitored for signs and symptoms of an injection reaction when you receive OCREVUS ZUNOVO. This will happen during all injections for at least 1 hour after your first injection, and for at least 15 minutes after all injections following the first injection.

Tell your healthcare provider or nurse if you get any of these symptoms:

• itchy skin
• trouble breathing
• nausea
• shortness of breath
• rash
• throat irritation or pain
• headache
• fatigue
• hives
• feeling faint
• swelling of the throat
• fast heartbeat
• tiredness
• fever
• dizziness
• coughing or wheezing
• redness on your face (flushing)

Additionally, for OCREVUS ZUNOVO:

• injection site pain
• swelling
• redness

These infusion and injection reactions can happen during or up to 24 hours after administration. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion or injection.

Infection:

Infections are a common side effect. OCREVUS and OCREVUS ZUNOVO increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with OCREVUS and OCREVUS ZUNOVO, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of OCREVUS or OCREVUS ZUNOVO. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with OCREVUS or OCREVUS ZUNOVO until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with ocrelizumab, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS or OCREVUS ZUNOVO. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS or OCREVUS ZUNOVO.

Weakened immune system: OCREVUS or OCREVUS ZUNOVO taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with ocrelizumab. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:

• thinking
• eyesight
• strength
• balance
• weakness on 1 side of your body
• using your arms or legs

Decreased immunoglobulins: OCREVUS and OCREVUS ZUNOVO may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving OCREVUS or OCREVUS ZUNOVO, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection. See “What is the most important information I should know about OCREVUS and OCREVUS ZUNOVO?”
• have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have a history of inflammatory bowel disease or colitis.
• have had a recent vaccination or are scheduled to receive any vaccinations.

You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with OCREVUS or OCREVUS ZUNOVO. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with OCREVUS or OCREVUS ZUNOVO and until your healthcare provider tells you that your immune system is no longer weakened.

When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with OCREVUS or OCREVUS ZUNOVO. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with OCREVUS or OCREVUS ZUNOVO, talk to your healthcare provider.

If you have a baby and you received OCREVUS or OCREVUS ZUNOVO during your pregnancy, it is important to tell your baby’s healthcare provider about receiving OCREVUS or OCREVUS ZUNOVO so they can decide when your baby should be vaccinated

• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if OCREVUS and OCREVUS ZUNOVO will harm your unborn baby. You should use birth control (contraception) during treatment with OCREVUS and OCREVUS ZUNOVO and for 6 months after your last dose of OCREVUS or OCREVUS ZUNOVO. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving OCREVUS or OCREVUS ZUNOVO.
• are breastfeeding or plan to breastfeed. It is not known if OCREVUS and OCREVUS ZUNOVO pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS or OCREVUS ZUNOVO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of OCREVUS and OCREVUS ZUNOVO?

OCREVUS and OCREVUS ZUNOVO may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer: Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness

The most common side effects of OCREVUS ZUNOVO include:

• Injection reactions
• Respiratory tract infections
• Skin infections

These are not all the possible side effects of OCREVUS and OCREVUS ZUNOVO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.

For more information, go to https://www.OCREVUS.com or call 1-844-627-3887. Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide for OCREVUS.

Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide for OCREVUS ZUNOVO.

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Media Contact:

Michelle McCourt, (650) 467-6800

Advocacy Contact:

Lily Rose Atherton, (202) 713-0083

Investor Contacts:

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Bruno Eschli, +4161 68 75284

Source: Genentech

FAQ

What is Ocrevus Zunovo and what has the FDA approved it for?

Ocrevus Zunovo is a subcutaneous injection of ocrelizumab & hyaluronidase-ocsq. The FDA has approved it for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

How often is Ocrevus Zunovo (RHHBY) administered?

Ocrevus Zunovo is administered twice a year as an approximately 10-minute subcutaneous injection by a healthcare professional.

What were the key findings from the Phase III OCARINA II trial for Ocrevus Zunovo (RHHBY)?

The trial showed no clinically significant difference in blood levels compared to IV administration, consistent safety and efficacy profiles, 97% suppression of relapse activity and MRI lesions, and over 92% patient satisfaction with subcutaneous administration.

What are the main side effects of Ocrevus Zunovo (RHHBY)?

The most common adverse events were injection reactions, with 49% of participants experiencing a reaction after the first injection. All reactions were mild or moderate and didn't lead to treatment withdrawal.